| CTRI Number |
CTRI/2025/07/091530 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Mifepristone in various doses for treatment of uterine fibroid |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of mifepristone in different doses in management of patients with uterine leiomyoma- a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angela Sehra |
| Designation |
Senior consultant |
| Affiliation |
Maharaja Agarsen Hospital |
| Address |
Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi
West DELHI 110026 India |
| Phone |
7011959875 |
| Fax |
|
| Email |
asehra2006@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jyotsna Puri |
| Designation |
Junior resident |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi
West DELHI 110026 India |
| Phone |
7011959875 |
| Fax |
|
| Email |
jyotsnapuri1996@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jyotsna Puri |
| Designation |
Junior resident |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi
West DELHI 110026 India |
| Phone |
7011959875 |
| Fax |
|
| Email |
jyotsnapuri1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Hospital, Punjabi Bagh, New Delhi, India Pincode- 110026 |
|
|
Primary Sponsor
|
| Name |
Jyotsna Puri |
| Address |
Maharaja Agrasen hospital, West Punjabi Bagh, New Delhi-110026 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyotsna Puri |
Maharaja Agarsen Hospital |
Department of obstetrics and gynecology, Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi West DELHI |
7011959875
jyotsnapuri1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitonal Ethics Committee of Maharaja Agrasen Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab Mifepristone |
10 mg tablet will be given once daily for period of three months |
| Intervention |
Tablet Mifepristone |
Dose of 25 mg to be given once daily for three months (based on clinical decision). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Women between 20-50 years of age with single or multiple fibroids
2. Symptomatic (menorrhagia, polymenorrhea, dysmenorrhoea, abdominal lump, dull aching lower abdominal pain, dyspareunia) or
3. Asymptomatic |
|
| ExclusionCriteria |
| Details |
1. USG suggestive of adenomyosis, endometriosis adnexal mass for the above symptoms.
2. More than 16-week gravid size uterus
3. Fibroids greater than 10 cm by ultrasound
4. Renal or hepatic dysfunction
5. Current genital infection
6. Endometrial hyperplasia with atypia
7. Hormonal medication (Progestogens or GnRH) within 3 months
8. Women desiring pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in symptoms after treatment in both groups
2. Change in Quality of life as assessed by Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire after treatment
3. Change in PBAC and Hemoglobin among both the groups
4. Change in size of uterine myoma on USG
|
at baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of Adverse effects |
At 3 moths |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Minimum 35 patients in each group with uterine
fibroids attending gynaecology department of Maharaja Agrasen Hospital, New
Delhi will be included in this study. Patients who did not meet the inclusion
criteria will be excluded from the study. During first visit patients will be
enrolled only after taking written inform consent & all demographic and
clinical detail will be taken as per case record form. Further investigations would
be done which are part of standard medical care advised to all fibroid
patients, these includes, ABO/Rh grouping, Complete blood count (CBC) with ESR,
hemoglobin, liver function tests (S.bilirubin, ALT & AST enzyme levels) and
kidney function tests (Blood urea and serum creatinine). Trans-abdominal ultrasonography
will be done for number, size and volume of myomas. PAP smear will be done to rule
out any cervical pathology and endometrial biopsy to rule out any malignancy. Here,
patients included in the study will be prescribed Tab mifepristone 10 mg or
25mg (based of clinical decision) once daily for 3 months.
A pictorial blood assessment chart (PBAC) chart
will be given before starting treatment & during follow up after 3 months
of treatment. UFS-QOL questionnaire will be administered. Patients will be counselled
regarding possible side effects to mifepristone like headache, hot flushes,
breast pain, fatigue, etc. Follow up would be done at 3 months of treatment and
patients will be evaluated for decrease in bleeding by PBAC-Score, decrease in pain
symptoms (abdomen pain, dysmenorrhoea, dyspareunia, pelvic pain and pressure
symptoms) by visual analogue scale, assessment of hemoglobin, liver function
and kidney function would be done, reduction in size of fibroid will be
assessed by ultrasonography and change in quality of life by using UFS-QOL questionnaire.
PAP smear and endometrial biopsy (if indicated) will be done. |